A 1556: Enacts the "food safety and chemical disclosure act"; prohibits certain food additives and food color additives; provides that in an action to enforce compliance, the recognition by the federal food and drug administration of any of these substances as safe may not be alleged as a defense; establishes requirements for the reporting of GRAS (generally recognized as safe) substances.

  
  STATE OF NEW YORK ________________________________________________________________________ 1556 2025-2026 Regular Sessions  IN ASSEMBLY January 10, 2025 ___________ Introduced by M. of A. KELLES, COLTON, EPSTEIN, GIBBS, GLICK, JACKSON, LEE, LEVENBERG, RAGA, REYES, ROSENTHAL, SAYEGH, SEAWRIGHT, SHIMSKY, SIMON, STECK, STIRPE, TAPIA -- read once and referred to the Committee on Agriculture AN ACT to amend the agriculture and markets law and the education law, in relation to prohibiting certain food additives and food color addi- tives and to the reporting of GRAS substances The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. The section heading of section 199-a of the agriculture and 2 markets law, as amended by chapter 797 of the laws of 1961, is amended 3 and a new subdivision 5 is added to read as follows: 4 Prohibition as to adulterated or misbranded food and certain food 5 additives and food color additives intended for human consumption. 6 5. (a) Notwithstanding any other provision of law to the contrary, 7 commencing one year after the effective date of this subdivision, it 8 shall be unlawful for any person, firm, association, or corporation to 9 manufacture, compound, brew, distill, produce, process, sell, deliver, 10 distribute, hold, offer or expose for sale any of the following 11 substances as food additives or food color additives or any food or food 12 product containing any of the following substances intended for human 13 consumption: 14 (i) FD&C Red No. 3; 15 (ii) Potassium bromate; or 16 (iii) Propylparaben. 17 (b) Notwithstanding the provisions of paragraph (a) of this subdivi- 18 sion, a store shall be permitted to sell, deliver, distribute, hold, 19 offer or expose for sale any food or food product containing any of the 20 substances listed in paragraph (a) of this subdivision until the expira- 21 tion date, "best by" date, or "sell by" date printed on the packaging of 22 the food or food product by the manufacturer or producer, but no later EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD01051-02-5 
 A. 1556 2 1 than three years after the effective date of this subdivision, provided, 2 however, that: 3 (i) the store sells food or food products at retail and is not prima- 4 rily engaged in the sale of food for consumption on the premises; 5 (ii) the store is independently owned and operated by a business that 6 employs ten or fewer persons; and 7 (iii) the food or food product was acquired by the business. 8 (c) Within thirty days of the effective date of this subdivision, the 9 commissioner shall amend the exemption list maintained pursuant to 10 subdivision three of this section to indicate that in this state the 11 substances prohibited in this subdivision shall not be deemed to be safe 12 for human consumption on or after one year after the effective date of 13 this subdivision. 14 § 2. The education law is amended by adding a new section 915-a to 15 read as follows: 16 § 915-a. Prohibiting the sale of foods containing synthetic color 17 additives. 1. No foods or beverages, including competitive foods as 18 defined under 7 CFR 210.11(a)(2) and meals reimbursed under programs 19 authorized by the federal Richard B. Russell National School Lunch Act 20 (Public Law 113-79) and the federal Child Nutrition Act of 1966 (42 21 U.S.C. Sec. 1771 et seq.), containing any of the following substances 22 shall be sold in any public school within the state: 23 a. FD&C Red No. 3 24 b. FD&C Red No. 40 25 c. FD&C Blue No. 1 26 d. FD&C Blue No. 2 27 e. FD&C Green No. 3 28 f. FD&C Yellow No. 5 29 g. FD&C Yellow No. 6 30 2. A school may permit the sale of foods and beverages that do not 31 comply with subdivision one of this section if the sale of such items 32 takes place either: 33 a. off and away from the premises of the school; or 34 b. on school premises at least one-half hour after the end of the 35 school day. 36 § 3. Section 198 of the agriculture and markets law is amended by 37 adding a new subdivision 7-a to read as follows: 38 7-a. For purposes of this section, the term "generally recognized as 39 safe substance" or "GRAS substance" means any substance added to food 40 that is not exempted from the definition of "food additive" under subdi- 41 vision seven of this section because it is generally recognized, among 42 experts qualified by scientific training and experience to evaluate its 43 safety, as having been adequately shown to be safe under the conditions 44 of its intended use: 45 (a) either through scientific procedures using the same quantity and 46 quality of scientific evidence as is required to obtain approval of the 47 substance as a food additive; or 48 (b) for a substance used in food prior to January first, nineteen 49 hundred fifty-eight, through experience based on common use in food. 50 § 4. Subdivision 4 of section 199-a of the agriculture and markets 51 law, as amended by chapter 671 of the laws of 1966, is amended to read 52 as follows: 53 4. All data submitted to the commissioner in support of the food or 54 color additives report under this section shall be considered confiden- 55 tial by the commissioner and shall not be revealed to any person other 56 than to a person authorized by the commissioner in the performance of 
 A. 1556 3 1 [his] their official duties under this article. In case of an actual 2 controversy as to the validity of an order or decision of the commis- 3 sioner respecting the test data or report in which a proceeding to 4 review has been instituted as authorized by section two hundred two-c of 5 this article the petition, data and report shall be transmitted by the 6 commissioner to the clerk of the court in which the review proceeding is 7 instituted, together with a record of the proceedings on which the 8 commissioner based [his] the order or decision, and such transmittal 9 shall not be construed to be a violation of confidence. Subdivisions 10 two and three of this section shall not apply to food additives or color 11 additives which are safe within the meaning of the federal food, drug 12 and cosmetic act as amended. 13 § 5. The agriculture and markets law is amended by adding a new 14 section 199-g to read as follows: 15 § 199-g. Reporting of GRAS substances. 1. a. Except as provided in 16 subdivision two of this section, unless a report described in paragraph 17 b of this subdivision has been submitted to the commissioner and such 18 report is made available in the database described in subdivision five 19 of section one hundred ninety-nine-b of this article, and notwithstand- 20 ing any other provision of law to the contrary, it shall be unlawful for 21 any person, firm, association, or corporation to: 22 (i) sell or offer or expose for sale for use in or on food, or to use 23 in the manufacturing, compounding, brewing, distilling, producing, or 24 processing of any food or food product, any GRAS substance or combina- 25 tion of GRAS substances; 26 (ii) make any new use of any GRAS substance or combination of GRAS 27 substances in or on food; or 28 (iii) sell or offer or expose for sale any food or food product 29 containing any GRAS substance or combination of GRAS substances. 30 b. The report required pursuant to paragraph a of this subdivision 31 shall include but not be limited to the following information: 32 (i) Signed statements and a certification, including: 33 (1) the date and signature of a responsible official of the reporter 34 or reporting organization; 35 (2) the name and address of the reporter or reporting organization; 36 (3) the name of any GRAS substances discussed in the report, using an 37 appropriately descriptive term; 38 (4) intended conditions for the use of any GRAS substance discussed in 39 the report, including the foods in which the substance will be used, the 40 levels of such use in such foods, and the purposes for which the 41 substance will be used, including, when appropriate, a description of 42 any subpopulation expected to consume such GRAS substance or substances; 43 (5) the statutory basis for the conclusion of GRAS status; 44 (6) a statement that the reported substance is not subject to the 45 premarket approval requirements of the federal food, drug, and cosmetic 46 act based on the conclusion that the notified substance is GRAS under 47 the conditions of its intended use; 48 (7) a statement that, if asked to see the data and information that 49 are the basis for the GRAS conclusion, the reporter will agree to: 50 (A) make the data and information available to the commissioner; and 51 (B) upon the commissioner's request, both of the following procedures 52 for making the data and information available to the commissioner: 53 (I) allow the commissioner to review and copy the data and information 54 during customary business hours at the address specified for where these 55 data and information will be available; and 
 A. 1556 4 1 (II) provide a complete copy of the data and information either in an 2 electronic format or on paper; 3 (8) views as to whether any of the data and information in the GRAS 4 report are exempt from disclosure under the freedom of information law; 5 (9) certifications that, to the best of the reporter's knowledge, the 6 GRAS report is a complete, representative, and balanced submission that 7 includes both unfavorable and favorable information known to the repor- 8 ter and pertinent to the evaluation of the safety and GRAS status of the 9 use of the substance; and 10 (10) the name and position or title of the person who signs the GRAS 11 report. 12 (ii) The identity, method of manufacture, specifications, and physical 13 or technical effect of the notified substance, including: 14 (1) scientific data and information that identifies the GRAS 15 substance, including: 16 (A) examples of appropriate data and information including the chemi- 17 cal name, applicable registry numbers (such as a chemical abstracts 18 service (CAS) registry number or an enzyme commission (EC) number), 19 empirical formula, structural formula, quantitative composition, and 20 characteristic properties; and 21 (B) when the source of a notified substance is a biological material, 22 data and information sufficient to identify: 23 (I) the taxonomic source (e.g., genus, species) of the GRAS substance, 24 including, as applicable, data and information at the sub-species level 25 (e.g., variety, strain); 26 (II) the part of any plant or animal used as the source of the GRAS 27 substance; and 28 (III) any known toxicants that could be in the source of the GRAS 29 substance; 30 (2) a description of the method of manufacture of the GRAS substance 31 in sufficient detail to evaluate the safety of the notified substance as 32 manufactured; 33 (3) specifications for food-grade material; and 34 (4) when necessary to demonstrate safety, relevant data and informa- 35 tion bearing on the physical or other technical effect the GRAS 36 substance is intended to produce, including the quantity of the GRAS 37 substance required to produce such effect. 38 (iii) Dietary exposure to the notified substance, including informa- 39 tion about dietary exposure (i.e., the amount of relevant substances 40 that consumers are likely to eat or drink as part of a total diet), 41 including: 42 (1) an estimate of dietary exposure to the notified substance that 43 includes exposure from its intended use and all sources in the diet; 44 (2) when applicable, an estimate of dietary exposure to any other 45 substance that is expected to be formed in or on food because of the use 46 of the notified substance (e.g., hydrolytic products or reaction 47 products); 48 (3) when applicable, an estimate of dietary exposure to any other 49 substance that is present with the notified substance either naturally 50 or due to its manufacture (e.g., contaminants or by-products); 51 (4) sources of any food consumption data used to estimate dietary 52 exposure, in accordance with clauses one through three of this subpara- 53 graph; and 54 (5) any assumptions made to estimate dietary exposure, in accordance 55 with clauses one through three of this subparagraph. 
 A. 1556 5 1 (iv) Self-limiting levels of use in circumstances where the amount of 2 the notified substance that can be added to human food or animal food is 3 limited because the food containing levels of the notified substance 4 above a particular level would become unpalatable or technologically 5 impractical. 6 (v) If the statutory basis for GRAS status is through experience based 7 on common use in food, evidence of a substantial history of consumption 8 of the notified substance for food use by a significant number of 9 consumers prior to January first, nineteen hundred fifty-eight. 10 (vi) A narrative that provides the basis for the conclusion of GRAS 11 status, including: 12 (1) an explanation for why the data and information in the report 13 provide a basis for that the notified substance is safe under the condi- 14 tions of its intended use. Such explanation shall address the safety of 15 the notified substance, considering all dietary sources and taking into 16 account any chemically or pharmacologically related substances in such 17 diet, and identify what specific data and information discussed in 18 accordance with this clause are generally available and not generally 19 available, by providing citations to the list of data and information 20 required in subparagraph (vii) of this paragraph; 21 (2) an explanation of how the generally available data and information 22 relied on to establish safety in accordance with clause one of this 23 subparagraph provides a basis for the conclusion that the reported 24 substance is generally recognized, among qualified experts, to be safe 25 under the conditions of its intended use; 26 (3) either: 27 (A) data and information that are, or may appear to be, inconsistent 28 with the conclusion of GRAS status; or 29 (B) a statement that the available data and information was reviewed 30 and the reporter is not aware of any data and information that are, or 31 may appear to be, inconsistent with the conclusion of GRAS status; 32 (4) if any data and information in the report is exempt from disclo- 33 sure under the freedom of information law, a statement that identifies 34 such data and information; and 35 (5) for non-public, safety-related data and information considered in 36 reaching a conclusion of GRAS status, an explanation of how there could 37 be a basis for a conclusion of GRAS status if qualified experts do not 38 have access to such data and information. 39 (vii) A list of the generally available data, information, and methods 40 the notifier cites in the GRAS notice, including: 41 (1) a list of all of the data and information required by subparagraph 42 (vi) of this paragraph to provide a basis for determining that the noti- 43 fied substance is safe under the conditions of its intended use, as 44 described in accordance with clause one of subparagraph (vi) of this 45 paragraph; and 46 (2) identification of specific data and information listed in accord- 47 ance with clause one of this subparagraph that are generally available 48 and not generally available. 49 (viii) Any previous GRAS substance notices submitted to the federal 50 food and drug administration on the reported substance and the federal 51 food and drug administration's responses. 52 (ix) All relevant currently available safety information. 53 2. The following substances are exempt from the reporting requirements 54 of subdivision one of this section: 55 a. Any GRAS substance for which the federal food and drug adminis- 56 tration has received a GRAS notice and issued a letter stating that the 
 A. 1556 6 1 federal food and drug administration has no questions regarding the 2 conclusion that the substance is generally recognized as safe under its 3 intended conditions of use; 4 b. Any substances recognized in federal regulations as prior sanc- 5 tioned or GRAS substances for use in food or food packaging; 6 c. Any food contact substance for which there is an effective premar- 7 ket notification demonstrating safety for its intended use; 8 d. Any substances subject to regulation approving its intended use for 9 food; 10 e. A food ingredient of natural biological origin that has been widely 11 consumed for its nutrient properties in the United States prior to Janu- 12 ary first, nineteen hundred fifty-eight without known detrimental 13 effects, which is subject only to conventional processing as practiced 14 prior to January first, nineteen hundred fifty-eight, and for which no 15 known safety hazard exists; 16 f. Any substance for which the federal food and drug administration 17 has received a new dietary ingredient notification and issued a letter 18 of acknowledgement without objection that the substance is safe under 19 its notification's intended conditions of use; and 20 g. Any substance determined safe to be added to foods by the commis- 21 sioner through rulemaking. 22 3. Any person may file a report to the commissioner under this 23 section. 24 4. A small business, defined as a business that is independently owned 25 and operated and employs ten or fewer persons, shall be exempt from the 26 requirements of this section. 27 5. Data establishing the general recognition of safety shall be based 28 on publicly available information and shall not be based on trade 29 secrets. 30 § 6. Section 199-b of the agriculture and markets law is amended by 31 adding a new subdivision 5 to read as follows: 32 5. The commissioner: 33 a. shall make reports submitted pursuant to section one hundred nine- 34 ty-nine-g of this article available to the public in a database on its 35 website. The database shall: 36 (i) be searchable by members of the public; 37 (ii) enable consumers to download and print displayed information; and 38 (iii) accommodate reasonably anticipated and actual public use. 39 b. shall redact from the public report any information that has been 40 designated by the submitter as a trade secret, provided, however, that 41 data establishing the general recognition of safety shall not be redact- 42 ed; 43 c. shall update the database with any new information that the commis- 44 sioner receives relating to the safety of the GRAS substance; 45 d. may refuse to list a GRAS substance if the commissioner determines 46 the report does not contain the information required by section one 47 hundred ninety-nine-g of this article; 48 e. shall provide an interim progress report concerning efforts to 49 develop and implement the database system required by this subdivision, 50 which shall include: 51 (i) a projected completion date; 52 (ii) a description of obstacles to development and implementation of 53 the database system; and 54 (iii) an estimate of the costs to complete the implementation of the 55 database system; and 
 A. 1556 7 1 f. may charge a fee to the reporter of a GRAS substance in order to 2 recover the costs incurred in listing such GRAS substance and maintain- 3 ing the database. 4 § 7. The second undesignated paragraph of section 202-c of the agri- 5 culture and markets law, as amended by chapter 671 of the laws of 1966, 6 is amended to read as follows: 7 The commissioner may institute such action at law or in equity as may 8 appear necessary to enforce compliance with sections one hundred nine- 9 ty-nine-a, one hundred ninety-nine-g, two hundred and two hundred one of 10 this article, and any rule or order respecting a GRAS substance, food 11 additive, or color additive promulgated pursuant to sections one hundred 12 ninety-nine-b and two hundred fourteen-b of this article and, in addi- 13 tion to any other remedy under this chapter or otherwise, may apply for 14 relief by injunction to protect the public interest without being 15 compelled to allege or prove that an adequate remedy at law does not 16 exist. In an action instituted by the commissioner to enforce compliance 17 with said sections one hundred ninety-nine-a, two hundred and two 18 hundred one the commissioner shall not be required to prove that the 19 food, food additive or color additive mentioned in the complaint is 20 unsafe and the claim or defense of the defendant as to its safety shall 21 be immaterial, provided, however, that the recognition by the federal 22 food and drug administration of a food additive or color additive as 23 safe may be alleged as a proper defense. 24 § 8. This act shall take effect on the one hundred eightieth day after 25 it shall have become a law.